FDA Medical Device Recalls (openFDA)
AVID Medical, Inc.: Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit
- Recall number
- Z-1741-2025
- Recalling firm
- AVID Medical, Inc.
- Product
- Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit
- Status
- Open, Classified
- Initiated
- 2025-03-31
- Posted
- 2025-05-09
- Terminated
- not on file
- Reason
- An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
- Root cause
- Nonconforming Material/Component
- Action
- An URGENT: MEDICAL DEVICE RECALL NOTIFICATION dated 3/31/25 was emailed to consignees. The notification indicates that this recall is due to Ethicon having recalled PDS II, PDS Plus, PROLENE, and ATHIBOND EXCEL sutures, which are components in the convenience kits being recalled by the recalling firm. Consignees are being instructed to discontinue use of the Johnson & Johnson Ethicon Sutures contained inside the recalled AVID kits identified in the recall notification and to add the provided labels to affected kits to ensure recalled sutures are discarded. Distributors are asked to forward the provided recall notification to their customers to which product was further distributed. Consignees are asked to return the provided response form via email. Questions regarding this recall event are to be directed to your distributor or sales representative.
- Quantity
- 72 units
- Distribution
- US Nationwide distribution in the states of IL & LA.
- Lot, serial or model codes
- Model No. ADVC800-03; UDI: 10809160450703; Lot Code: 1640852; Exp: 2/4/2028.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1047429
- Firm city
- Toano
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28